Clinical Trials

Numerous clinical trials evaluate bromfenac sodium for ophthalmic indications, focusing on postoperative ocular pain and inflammation following cataract surgery, pterygium resection, and vitrectomy, as well as retinal conditions like diabetic macular edema and acute pseudophakic cystoid macular edema. Conducted across multiple phases and funded by both pharmaceutical sponsors and academic medical institutions, these studies span recruitment statuses ranging from active and completed to withdrawn and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07178639 RECRUITING
Macular Oedema; Cataract Surgery; NSAID (Non-Steroidal Anti-Inflammatory Drug)
Nemocnice Kolín
 2025-08-01
NCT05107921 UNKNOWN
Familial Exudative Vitreoretinopathies
Seoul National University Hospital
 2021-11-01 PHASE2
NCT05158699 TERMINATED
Macular Edema; Cystoid Macular Edema; Retinal Disease; Cataract; Lens Diseases; Eye Diseases
Luigi Rondas
 2021-10-13 PHASE3
NCT07696104 COMPLETED
Pseudophakic Cystoid Macular Edema
Pomeranian Medical University Szczecin
 2020-10-14 PHASE4
NCT06785090 COMPLETED
Cataract; Cystoid Macular Edema After Phacoemulsification
Inas Abd
 2023-05-01 PHASE4
NCT06130384 COMPLETED
Pain; Intravitreal Injection; Pain, Acute
Wills Eye
 2021-03-01 PHASE4
NCT07090044 COMPLETED
Vein Occlusion; Macular Degeneration Choroidal Neovascularization; Macular Edema; Diabetic Retinopathy
Retina Research Institute, LLC
 2021-08-20 PHASE4
NCT04940338 COMPLETED
Cystoid Macular Edema Following Cataract Surgery
Klinički Bolnički Centar Zagreb
 2021-05-01 PHASE4
NCT05006911 UNKNOWN
Presbyopia
Optall Vision
 2021-08-14 PHASE1
NCT03751059 UNKNOWN
Glaucoma
Cindy Hutnik
 2020-11 PHASE4
NCT05001243 UNKNOWN
Presbyopia
Optall Vision
 2021-08-10 PHASE1
NCT04343222 COMPLETED
Intravitreal Injections; IVI
University of Wisconsin, Madison
 2019-06-27 PHASE4
NCT03578276 COMPLETED
Cataract
Carolina Eyecare Physicians, LLC
 2018-06-22 PHASE4
NCT03831984 UNKNOWN
Cataract
Hospital de La Luz
 2018-03-01 PHASE4
NCT03597867 COMPLETED
Ocular Inflammation
University of Trieste
 2018-04-25 PHASE3
NCT01478555 WITHDRAWN
Dry Eye Disease
Sun Pharmaceutical Industries Limited
 2018-01 PHASE2
NCT03317847 COMPLETED
Inflammation Eye
Azienda USL Reggio Emilia - IRCCS
 2017-10-16 PHASE4
NCT04022811 COMPLETED
Pterygium; Pain
Zhongshan Ophthalmic Center, Sun Yat-sen University
 2016-10 PHASE4
NCT03886779 COMPLETED
Treatment of Ocular Inflammation Associated With Cataract Surgery
Silverstein Eye Centers
 2013-10-30 PHASE4
NCT01774474 COMPLETED
Cystoid Macular Edema; Cataract; Diabetes Mellitus
Maastricht University Medical Center
 2013-07-10 PHASE3
NCT01847638 COMPLETED
Cataract; Retinal Edema; Inflammation
Melissa Toyos
 2013-04-01
NCT02681679 COMPLETED
Cataract
Sun Yat-sen University
 2014-10
NCT05715385 COMPLETED
Diabetic Macular Edema
Babasaheb Ambedkar Memorial Hospital
 2014-11 PHASE4
NCT02361645 COMPLETED
Vitreous Inflammation
Università degli Studi di Brescia
 2014-03 PHASE3
NCT02137161 COMPLETED
Cataract; Pseudoexfoliation Syndrome
Azienda USL Reggio Emilia - IRCCS
 2013-11 PHASE4
NCT01193504 UNKNOWN
Pseudophakia; Cataract Surgery
Innovative Medical
 2010-09 PHASE4
NCT01535443 COMPLETED
Inflammation; Cataract
Laboratorios Sophia S.A de C.V.
 2011-09 PHASE1
NCT01387464 COMPLETED
Cataract
Sun Pharmaceutical Industries Limited
 2011-07 PHASE2
NCT01212471 COMPLETED
Dry Eye Syndrome
Bausch & Lomb Incorporated
 2010-09 PHASE3
NCT01367249 COMPLETED
Pain; Inflammation; Cataract
Bausch & Lomb Incorporated
 2011-05 PHASE3
NCT01310127 COMPLETED
Inflammation; Pseudophakia
Toyos Clinic
 2010-11 PHASE4
NCT00805233 COMPLETED
Age-Related Macular Degeneration
Oregon Health and Science University
 2008-12 PHASE2
NCT00438243 WITHDRAWN
Cystoid Macular Edema
Johns Hopkins University
 2008-05 PHASE2
NCT00758199 COMPLETED
Cataracts
Bp Consulting, Inc
 2008-07 PHASE4
NCT01023724 COMPLETED
Post Operative Anterior Chamber Inflammation (Flare)
Bucci Laser Vision Institute
 2009-12 PHASE4
NCT01021761 COMPLETED
Cataracts
Frank A. Bucci, Jr., M.D.
 2009-10 PHASE4
NCT01001806 COMPLETED
Cataracts
Frank A. Bucci, Jr., M.D.
 2009-10 PHASE4
NCT00853970 COMPLETED
Pain; Inflammation
Bausch & Lomb Incorporated
 2009-02 PHASE3
NCT00828477 COMPLETED
Intraocular Pressure
Bp Consulting, Inc
 2009-01 PHASE4
NCT00758628 COMPLETED
Diabetic Macular Edema
Bp Consulting, Inc
 2008-08 PHASE4
NCT00595543 COMPLETED
Acute Pseudophakic Cystoid Macular Edema
Bp Consulting, Inc
 2008-01 PHASE4
NCT00758784 COMPLETED
Dry Eye Disease
Bausch & Lomb Incorporated
 2008-08-13 PHASE2
NCT00704418 COMPLETED
Cataract
Bausch & Lomb Incorporated
 2008-06 PHASE3
NCT00703781 COMPLETED
Cataract
Bausch & Lomb Incorporated
 2008-06 PHASE3
NCT00469781 COMPLETED
Cystoid Macular Edema,; Retinal Thickening
Center For Excellence In Eye Care
 2007-05 PHASE4
NCT00520260 COMPLETED
Dry Eye Disease; Ocular Comfort
Florida Eye Microsurgical Institute
 2007-08 PHASE4
NCT00585975 COMPLETED
Cataract Surgery
Bausch & Lomb Incorporated
 2007-10 PHASE2
NCT00469690 COMPLETED
Cataract
Innovative Medical
 2007-05 PHASE4
NCT00423007 COMPLETED
Allergic Conjunctivitis
Bausch & Lomb Incorporated
 2006-11 PHASE3
NCT00333918 COMPLETED
Pain; Inflammation
Bausch & Lomb Incorporated
 2006-06 PHASE3
NCT00198445 COMPLETED
Postoperative Complications; Cataract
Bausch & Lomb Incorporated
 2003-05 PHASE3
NCT00377546 COMPLETED
Vitrectomy
Innovative Medical
 PHASE4
NCT00491166 UNKNOWN
Diabetic Macular Edema
Ophthalmic Consultants of Boston
 2007-06 PHASE1
NCT00347503 COMPLETED
Cataract
Innovative Medical
 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-09-17)

Check the Bromfenac Sodium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bromfenac sodium acts as a nonsteroidal anti-inflammatory agent that directly inhibits cyclooxygenase-1 and cyclooxygenase-2 enzymes, thereby blocking the enzymatic conversion of arachidonic acid into pro-inflammatory prostaglandins. This inhibition attenuates downstream vascular permeability and cellular inflammatory signaling cascades in ocular tissues, effectively reducing postoperative pain and inflammation associated with cataract surgery and related ophthalmic conditions.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.